Effect of Cardiorespiratory Changes on Carotid Flow Time During Lung Resection Surgery
Noninvasive Perioperative Hemodynamic Monitoring In Thoracic Surgery: A Prospective Observational Study
Cardiorespiratory changes during lung resection surgery, even though generally well tolerated, may lead to hemodynamic compromise, reducing venous return to the heart and hence cardiac output.
Carotid corrected flow time is widely regarded as non-invasive index of preload status, yet its dynamic relationship with cardiac output, especially in surgical population is not well-studied. Understanding how cardiorespiratory changes affect carotid flow time in anesthesized patients remains limited. This study investigates corrected carotid flow time response to anesthesia, lateral position, one-lung ventilation, open chest, capnothorax, lung recruitment and volume expansion, hypothesizing that cFT declines in association with CO reduction during lung resection.
The secondary interest of the study is to test whether carotid flow time and its recruitment-induced change can adequately predict fluid response during one-lung ventilation. In addition, the baseline preoperative carotid flow time and its position-induced change are studied as potential predictors of hemodynamic tolerance to lung recruitment and fluid response, respectively.
Finally, the purpose of this study is to see if cardiorespiratory changes and volume expansion affect cerebral blood volume during lung resection surgery.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Manuel Granell Gil Prof.
- Telefonszám: +34 609232031
- E-mail: margry@uv.es
Tanulmányi helyek
-
-
-
Valencia, Spanyolország
- Toborzás
- Hospital General Valencia
-
Kapcsolatba lépni:
- Prof. Manuel Granell, Dr
- Telefonszám: +34 609232031
- E-mail: margry@uv.es
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
Inclusion Criteria:
- patients scheduled to undergo thoracosocpic lung resection surgery
Exclusion Criteria:
- carotid stenosis or abnormal anatomy of carotid artery that prevents visualization, emphysema, arrythmia
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
|---|
|
Longitudinal study
Repeated measurements design
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in corrected carotid artery flow (ccFT) in association with cardiorespiratory changes and volume expansion during lung resection surgery
Időkeret: enrollment phase (up to 2 years)
|
Doppler ultrasonography measurements are performed repeatedly at following timepoints: awake (seated), awake (supine), after intubation, after lateral decubitus position, after transition to one-lung ventilation, after pleura opening, after carbon dioxide insufflation, before lung recruitment, after first highest PEEP, after second highest PEEP, after optimal PEEP, before and after volume expansion. Statistical analysis: within-patient change (Friedman, Wilcoxon signed rank), correlation |
enrollment phase (up to 2 years)
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Diagnostic accuracy of corrected carotid flow time (ccFT) and recruitment - induced change in carotid corrected flow time (delta ccFTRM) in discriminating fluid responders during one-lung ventilation
Időkeret: enrollment phase (up to 2 years)
|
Corrected carotid flow time (ccFT) is measured by Doppler ultrasonography immediately before volume expansion (VE) and 5 min after it. Recruitment - induced change in carotid corrected flow time (delta cFTRM) is calculated from measurments obtained by Doppler utrasonography immediately before recruitment maneuver (RM) and at highest PEEP. delta ccFTRM = (ccFT before RM - ccFTafter RM) / ccFT before RM Fluid response is defined as > 15% increase in cardiac output (CO) following volume expansion (VE). Volume expansion is a 200-250 ml bolus of crystalloid solution performed after the recruitment maneuver (RM) at the discretion of attending anesthesiologist. Measurements are obtained by pulse contour analysis after immediately before volume expansion (VE) and 5 min after it. Stat- ROC curve Outcome measure - prognostic ability (AUC)of corrected carotid flow time (ccFT) and recruitment - induced change in carotid corrected flow time (delta ccFTRM) in predicting CO increase. |
enrollment phase (up to 2 years)
|
|
Diagnostic accuracy of baseline preoperative carotid flow time (ccFT) in discriminating between poor and good tolerance to recruitment maneuver and preoperative position-induced change in ccFT in discriminating fluid responders and non-responders.
Időkeret: enrollment phase (up to 2 years); statistical analysis (ROC); outcome measure - prognostic ability (AUC) of preoperative corrected carotid flow time (ccFT) and position - induced change in ccFT (delta ccFTRM) in predicting poor tolerance or CO increase
|
Baseline preoperative carotid corrected flow time (ccFT) is a preoperative carotid Doppler measurement in seated position. Position-induced change (delta ccFT-P) is calculated from measurments obtained by Doppler utrasonography in awake seated position and within approxiamtely 10-15 minutes in awake supine position. delta ccFTP = (ccFT awake seated - ccFTawake supine ) / ccFT awake seated Poor tolerance to lung recruitment is defined as TWA-MAP of 20% decrease from baseline or absolute value < 65 mmHg measured during recruitment period or 10 min after. Measurements are obtained by pulse contour analysis from immediately before recruitment maneuver to 5 min after it. Fluid response is defined as > 15% increase in cardiac output (CO) following volume expansion (VE). Volume expansion(VE) is a 200-250 ml bolus of crystalloid solution performed after the recruitment maneuver (RM) at discretion of attending anesthesiologist. |
enrollment phase (up to 2 years); statistical analysis (ROC); outcome measure - prognostic ability (AUC) of preoperative corrected carotid flow time (ccFT) and position - induced change in ccFT (delta ccFTRM) in predicting poor tolerance or CO increase
|
|
Change in cerebral blood volume index (CBVIl, CBVIr) in association with cardiorespiratory changes and volume expansion during lung resection surgery
Időkeret: enrollment phase (up to 2 years)
|
Doppler ultrasonography measurements are performed repeatedly at following timepoints: awake (seated), awake (supine), after intubation, after lateral decubitus position, after transition to one-lung ventilation, after pleura opening, after carbon dioxide insufflation, before lung recruitment, after first highest PEEP, after second highest PEEP, after optimal PEEP, before and after volume expansion. Statistical analysis: within-patient change (Friedman, Wilcoxon signed rank), correlation (with cardiac output) |
enrollment phase (up to 2 years)
|
|
Change in secondary hemodynamic and ventilatory variables in response to cardiorespiratory changes and volume expansion during lung resection surgery
Időkeret: enrollment phase (up to 2 years)
|
Hemodynamic variables (CO, SV, MAP, HR, dP/dt, Eadyn, PI, BIS, carotid diameter, resistivity index) are obtained from pulse contour analysis/ Doppler and respiratory variables (EtCO2, Ppeak, PEEP, TV, SpO2, FiO2, RR) are obtained from mechanical ventilator continuously during the same timepoints as primary variable. Outcome measure: all variables will be taken and reported at the following timepoints: awake (seated), awake (supine), after intubation, after lateral decubitus position, after transition to one-lung ventilation, after pleura opening, after carbon dioxide insufflation, before lung recruitment, after first highest PEEP, after second highest PEEP, after optimal PEEP, before and after volume expansion. Statistical analysis: within-patient change (Friedman, Wilcoxon signed rank), correlation |
enrollment phase (up to 2 years)
|
|
Comparative between-group analysis of primary and secondary variables in patients of different sex, ventilation protocol, operative side, recruitment tolerance and fluid response.
Időkeret: enrollment phase (up to 2 years)
|
Hemodynamic (CO, SV, MAP, HR, dP/dt, Eadyn, PI, BIS, carotid diameter, resistivity index) are obtained from pulse contour analysis/ Doppler and respiratory variables (EtCO2, Ppeak, PEEP, TV, SpO2, FiO2, RR) will be collected at following timepoints: awake (seated), awake (supine), after intubation, after lateral decubitus position, after transition to one-lung ventilation, after pleura opening, after carbon dioxide insufflation, before lung recruitment, after first highest PEEP, after second highest PEEP, after optimal PEEP, before and after volume expansion.
Comparative between-group analysis of variables response will be performed.
Groups are stratified by sex, ventilation protocol, operative side, recruitment tolerance and fluid response.
Statistical analysis: between-patient change (Mann-Whitney).
|
enrollment phase (up to 2 years)
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- Registro:24/2023
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .